Inglasia LTD · Quality by design

The eQMS that knows what you need next.

A compliant-by-design quality platform built by big-pharma Quality Experts with one hundred combined years on the floor. Mature on day one. Priced so quality is for everyone.

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21 CFR Part 11 EU GMP Annex 11 ICH Q9 ICH Q10 GAMP 5 Second Edition ISO 9001:2015 ALCOA+ 21 CFR Part 11 EU GMP Annex 11 ICH Q9 ICH Q10 GAMP 5 Second Edition ISO 9001:2015 ALCOA+
I. The Promise
Compliance so thorough it becomes effortless — giving teams the clarity to focus on what matters.
i.

Mature on day one

No "we'll add that in v2." Segregation of Duties, immutable audit trails, periodic review, legacy migration — all in the first release.

ii.

The button arrives when conditions are met

Every screen surfaces only the action you're authorised, trained, and qualified to take — right now. No menu safaris. No procedural ambiguity.

iii.

Smart, automated, enforcing

Built by pharma experts and validation engineers. The workflows already match what an MHRA, FDA, or EMA auditor expects — because the people who designed them have answered those auditors before.

iv.

Quality is for everyone

Fair subscription. Configuration in the admin UI rather than buried in consulting hours. The price of being inspection-ready should not be a six-figure tax on credibility.

II. The Platform

Five locked modules. One enforcement engine.

Learning Management
The authoritative source of training status across the platform. A single Training Gate API consumed identically by every other module — if a user isn't current on the governing SOP, the button does not render. Job-title changes trigger automatic recalculation of obligations and dropdown filtering across the tenant in real time.
Document Control
Closed-loop drafting with cryptographically verified check-in. Dynamic watermark transitions through Draft → Approved → Effective.
Deviations
Step-based guided forms. Sequential numbering reserved at submission, never wasted on abandoned drafts. Recurrence intelligence across sites.
CAPA
Nine-stage lifecycle with mandatory collaboration gates. Effectiveness verification before closure on Critical and Major actions.
Change Control
Multi-area impact assessment with a hard documentation gate at effectiveness. Temporary changes carry mandatory reversal plans.
III. The Signature Feature

The system literally gives you the button when you need it.

Most eQMS platforms ask users to navigate. We ask the platform. When a deviation is ready for approval — the Approve button appears. When training expires — the Take Training tile is what you see, not a locked screen. When a check-out is abandoned, the override button appears on the document itself.

The violation is prevented before it happens. The action is offered before it's asked for. This is the difference between a form library and a quality partner.

Compliant by Design
Deviations
REVIEW CYCLE COMPLETE
Owner
Test · QA Lead
Reviewers
3 of 3 signed
Training
SOP-007 v2.0 · Compliant
SoD Check
Passed
Initiate approval signature.
✓Electronic signature applied · —
✓21 CFR Part 11 § 11.50 · Signature UUID —
IV. Values

Inglasia Intuitor

Quality is not an act, it is a habit.

Discover our eight values. The promise on which we deliver our
eQMS solution.

Inglasia geometric mark

Want to know how Inglasia Intuitor achieves this in practice?
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V. Origin

Built by big-pharma Quality Experts. Not by a software house guessing at GxP.

Inglasia Intuitor was not assembled from a generic workflow engine and dressed in pharma vocabulary. It was specified, line by line, by people who have lived through MHRA inspections, FDA warning letters, and EMA pre-approval visits — and who have built the procedures that survive them.

The result is a first-generation platform that ships with the maturity of a fifth. Edge cases that surface in year three of competing systems — race conditions on training webhooks, deactivated signatories, abandoned check-outs, simultaneous numbering — are specified in the design documents on day one.

Over
100
Combined years of experience
on the floor
VI. Standards

Regulatory frameworks aren’t features. They ARE the foundation.

21 CFR Part 11
FDA · Subpart C
Electronic records and electronic signatures. Re-authentication at every signed event. Signature manifest non-removable.
EU GMP Annex 11
EMA · Computerised systems
Append-only audit trails, attributable to user identity, with UTC second-precision timestamps. Risk-based access control.
GAMP 5
ISPE · Category 5
Risk-proportionate validation. IQ/OQ/PQ scripts ship with each module. Configuration changes auto-flag validation impact.
ALCOA+
Data integrity
Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, and Available, enforced technically.
Quality is not an act,
it is a habit.
Aristotle
Inglasia · Brand philosophy
VII. Walkthrough

Let us show you the button.

A thirty-minute live walkthrough. We'll raise a deviation, route it through CAPA, and approve a controlled document — live, on your data shape. Bring your hardest audit question.

Request a walkthrough